Ovarian Cancer Clinical Trial
Mirena® IUD’s Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation
Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a large extent through COCs ability to reduce cell proliferation in the fallopian tube fimbriae (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an increasingly popular method of contraception, but it is not known if its use will reduce a woman's risk of IEOC. Mirena® use does not block ovulation in most women but it may release sufficient progestin to also reduce cell proliferation in the FTF. This study aims to evaluate the effects of the Mirena® IUD on cell proliferation in the FTF as a possible biomarker of protection against IEOC.
Women between 35 and 50 years of age (inclusive)
Women who will be scheduled to undergo an RRSO or RRs
Women who will have at least one fallopian tube removed for risk-reducing reasons (with or without removal of ovar(ies))
Women who are willing to have a Mirena® IUD inserted at least prior to risk-reducing surgery or who already have the Mirena® in place
Women using non-hormonal forms of contraception (Note: If a copper IUD is being used, the IUD must be removed prior to or at time of Mirena insertion.)
Any medical contraindication to use of a Mirena® IUD, including:
Pregnancy (a pregnancy test is required prior to study entry)
Known uterine anomaly that distorts the shape of the uterine cavity
Acute pelvic inflammatory disease
Postpartum endometritis or endometrial infection
Known or suspected uterine or cervical neoplasia
Known history or suspected breast cancer or other progestin-sensitive cancer
Uterine bleeding of unknown etiology.
Untreated acute cervicitis, vaginitis, or other lower genital tract infections
Acute liver disease or liver tumor (benign or malignant)
Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
Positive pregnancy test
Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena® IUD
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There are 5 Locations for this study
Basking Ridge New Jersey, 07920, United States
Middletown New Jersey, 07748, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Rockville Centre New York, , United States
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